List of services that can be provided can be customized to suit the requirements of the organization in Drug Discovery, Development, Manufacturing, Non-clinical, Clinical; Biotech, Biopharmaceuticals and Medical Devices, it includes, but not limited to the following:
Strategize the establishment of
- Corporate Quality & Regulatory Compliance
- Phase appropriate GMP requirements
- Quality Assurance
- Quality Control
- Quality Management Systems (GCP, GLP, GMP, ISO)
- Laboratory Management Systems
- EHS Management Systems
- Medical Devices Management Systems
- Information and Data Management Systems
Afore indicated can be aligned to the overall Business Strategy of the Organization – this includes, reworking / realignment of the systems and processes.
Training and mentoring in afore indicated standards
- Awareness
- Topics related to GCP, GLP, GMP, ISO
- Internal audit
- Deviation, CAPA,
- Data integrity
- Inspection readiness
- Validation and qualification
- Computerized system validation
- Regulatory topics
- Any other customized topic
Audits and regulatory inspections
- Assist in various types of audits: customer / sponsor, due-diligence, loss prevention-business risk, CSR, confidential information, data integrity, asset protection audits
- Conduct Walkthroughs
- Mock inspections
- Mock interactions / interviews
- Assist during regulatory inspections – USFDA, WHO, EMA, PMDA, ANVISA, National authorities (DCGI, CDSCO, NGCMA, NABL)
- Assist during Qualified Person (QP) inspections
- Assist in response preparation and CAPA as an outcome of regulatory inspections
Additional Services
- Data Integrity Governance framework
- Quality Governance framework
- Internal audits and management review
- Regulatory Surveillance Group
- Quality systems and compliance framework for collaborations / alliances / partnerships
- Whistleblower mechanism
- Accreditations and certifications
- Legal / compliance register
- Computerized system validation
- Validation and qualification
- Document preparation and review
- Research Quality Assurance for Discovery Chemistry, Discovery Biology, Bioinformatics
- Development Quality Assurance for Chemical Development, Biopharmaceutical Development and Formulation Development
- Transfer technology / Manufacturing Science And Technology (MSAT)
- Act as liaison between the regulatory agency (FDA, EMA, HPB, etc.) and the sponsor.
- Provide leadership role at companies to identify and hire personnel in quality assurance, quality control, regulatory affairs, regulatory compliance, validation, and materials management.
